Trial Outcomes & Findings for First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (NCT NCT05086315)

Last Updated: 2026-07-06

Results Overview

The DLT was defined as any of the following events during Cycle 1 (first 28 days) using NCI CTCAE v5.0 or ASTCT criteria, whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to disease progression. Hematologic DLTs included hematologic toxicities, bone marrow hypocellularity, decreased neutrophils lasting, febrile neutropenia, decreased platelet count lasting, anemia (all Grade 4), and Grade 3 thrombocytopenia. Non-hematologic DLTs included any Grade \>=3 toxicities except alopecia, Grade 3 fatigue, asthenia, fever, anorexia, constipation, nausea, vomiting, diarrhea, total parenteral nutrition, hospitalization related events, infection, bleeding, Grade 3 infusion related reaction and laboratory abnormalities, Grade 3 or 4 tumor lysis syndrome and isolated electrolyte abnormalities. Also, DLTs were any treatment related toxicity causing \>2 week delay in recovery to baseline/Grade \<=1 or requiring dose reduction.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

101 participants

Primary outcome timeframe

Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.

Results posted on

2026-07-06

Participant Flow

The study was conducted at 21 centers across 5 countries between 08 December 2021 and 13 June 2025. A total of 101 eligible participants were enrolled, including 69 in the Dose Escalation - Adult arm, 12 in the Dose Escalation - Pediatric arm, and 20 in the Dose Expansion - Adult arm. All enrolled participants received the study treatment.

Study included adult (\>=18 years) and pediatric (1 to \<18 years; \>=2 years in France) arms with dose escalation and dose expansion/optimization phases. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohorts A2, B and C) and pediatric arms (Cohort D) were not initiated. Only results from completed parts are reported.

Participant milestones

Participant milestones
Measure	Dose Escalation - Adult Arm: SAR443579 10-100 mcg/kg Adult participants with either relapsed or refractory acute myeloid leukemia (R/R AML) or high-risk myelodysplastic syndrome (HR-MDS) received SAR443579 intravenous (IV) infusion of 10 microgram per kilogram (mcg/kg) on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 30-300 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 750 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 800 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg Pediatric participants with R/R AML, B-cell acute lymphoblastic leukemia (B-ALL) or blastic plasmacytoid dendritic cell neoplasm (BPDCN) received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Overall Study STARTED	3	4	6	10	4	4	8	6	4	4	8	8	6	6	20
Overall Study COMPLETED	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	4	6	10	4	3	8	6	4	4	8	8	6	6	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Escalation - Adult Arm: SAR443579 10-100 mcg/kg Adult participants with either relapsed or refractory acute myeloid leukemia (R/R AML) or high-risk myelodysplastic syndrome (HR-MDS) received SAR443579 intravenous (IV) infusion of 10 microgram per kilogram (mcg/kg) on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 30-300 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 750 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 800 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg Pediatric participants with R/R AML, B-cell acute lymphoblastic leukemia (B-ALL) or blastic plasmacytoid dendritic cell neoplasm (BPDCN) received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Overall Study Adverse Event	0	0	2	4	0	1	0	0	0	0	0	1	0	0	3
Overall Study Progressive disease	3	3	2	4	3	2	6	5	4	3	8	5	5	4	7
Overall Study Poor compliance to protocol	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Overall Study Withdrawal by Subject	0	0	0	0	0	0	1	0	0	1	0	1	0	1	7
Overall Study Other	0	1	2	2	1	0	1	1	0	0	0	1	0	1	3

Baseline Characteristics

First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Escalation - Adult Arm: SAR443579 10-100 mcg/kg n=3 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 10 mcg/kg on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 30-300 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 750 mcg/kg n=6 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 800 mcg/kg n=10 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg n=6 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg n=6 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg n=6 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=20 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Total n=101 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 16.6 • n=9 Participants	65.3 years STANDARD_DEVIATION 19.6 • n=27 Participants	58.3 years STANDARD_DEVIATION 13.2 • n=267 Participants	61.0 years STANDARD_DEVIATION 15.8 • n=265 Participants	62.5 years STANDARD_DEVIATION 26.0 • n=568 Participants	55.8 years STANDARD_DEVIATION 24.6 • n=22 Participants	67.9 years STANDARD_DEVIATION 10.0 • n=23 Participants	68.5 years STANDARD_DEVIATION 13.5 • n=22 Participants	34.8 years STANDARD_DEVIATION 15.8 • n=178 Participants	61.3 years STANDARD_DEVIATION 22.4 • n=116 Participants	50.4 years STANDARD_DEVIATION 21.2 • n=2 Participants	62.8 years STANDARD_DEVIATION 18.4 • n=4 Participants	7.7 years STANDARD_DEVIATION 4.7 • n=190 Participants	9.0 years STANDARD_DEVIATION 6.4 • n=19 Participants	63.3 years STANDARD_DEVIATION 15.4 • n=18 Participants	54.2 years STANDARD_DEVIATION 23.7 • n=18 Participants
Sex: Female, Male Female	1 Participants n=9 Participants	1 Participants n=27 Participants	2 Participants n=267 Participants	2 Participants n=265 Participants	0 Participants n=568 Participants	1 Participants n=22 Participants	2 Participants n=23 Participants	1 Participants n=22 Participants	2 Participants n=178 Participants	2 Participants n=116 Participants	5 Participants n=2 Participants	3 Participants n=4 Participants	3 Participants n=190 Participants	2 Participants n=19 Participants	6 Participants n=18 Participants	33 Participants n=18 Participants
Sex: Female, Male Male	2 Participants n=9 Participants	3 Participants n=27 Participants	4 Participants n=267 Participants	8 Participants n=265 Participants	4 Participants n=568 Participants	3 Participants n=22 Participants	6 Participants n=23 Participants	5 Participants n=22 Participants	2 Participants n=178 Participants	2 Participants n=116 Participants	3 Participants n=2 Participants	5 Participants n=4 Participants	3 Participants n=190 Participants	4 Participants n=19 Participants	14 Participants n=18 Participants	68 Participants n=18 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=178 Participants	0 Participants n=116 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=190 Participants	0 Participants n=19 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants
Race/Ethnicity, Customized White	2 Participants n=9 Participants	3 Participants n=27 Participants	5 Participants n=267 Participants	5 Participants n=265 Participants	3 Participants n=568 Participants	2 Participants n=22 Participants	3 Participants n=23 Participants	3 Participants n=22 Participants	4 Participants n=178 Participants	2 Participants n=116 Participants	5 Participants n=2 Participants	5 Participants n=4 Participants	3 Participants n=190 Participants	3 Participants n=19 Participants	9 Participants n=18 Participants	57 Participants n=18 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=568 Participants	1 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=178 Participants	0 Participants n=116 Participants	0 Participants n=2 Participants	1 Participants n=4 Participants	0 Participants n=190 Participants	0 Participants n=19 Participants	2 Participants n=18 Participants	4 Participants n=18 Participants
Race/Ethnicity, Customized Asian	1 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	1 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	1 Participants n=23 Participants	1 Participants n=22 Participants	0 Participants n=178 Participants	0 Participants n=116 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	1 Participants n=190 Participants	2 Participants n=19 Participants	4 Participants n=18 Participants	11 Participants n=18 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	1 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=178 Participants	0 Participants n=116 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=190 Participants	0 Participants n=19 Participants	0 Participants n=18 Participants	1 Participants n=18 Participants
Race/Ethnicity, Customized Other	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=178 Participants	0 Participants n=116 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=190 Participants	0 Participants n=19 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants
Race/Ethnicity, Customized Not reported	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	2 Participants n=265 Participants	1 Participants n=568 Participants	1 Participants n=22 Participants	4 Participants n=23 Participants	2 Participants n=22 Participants	0 Participants n=178 Participants	2 Participants n=116 Participants	3 Participants n=2 Participants	2 Participants n=4 Participants	0 Participants n=190 Participants	1 Participants n=19 Participants	3 Participants n=18 Participants	21 Participants n=18 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=9 Participants	0 Participants n=27 Participants	1 Participants n=267 Participants	2 Participants n=265 Participants	0 Participants n=568 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=178 Participants	0 Participants n=116 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	2 Participants n=190 Participants	0 Participants n=19 Participants	2 Participants n=18 Participants	7 Participants n=18 Participants

PRIMARY outcome

Timeframe: Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.

Population: All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=3 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 n=4 Participants Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 n=6 Participants Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 n=10 Participants Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg n=6 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg n=6 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg n=6 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.

Population: Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohort C) was not initiated. Therefore, no analyses were conducted.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks.

Population: All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2 and D) was not initiated. Therefore, no analyses were conducted.

The CRc rate was defined as the percentage of participants who had a response of complete remission (CR), CR with partial hematologic recovery (CRh) or CR with incomplete hematologic recovery (CRi) according to modified AML International Working Group (IWG) 2003 response criteria.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=20 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Expansion (Cohorts A1, A2 and D): Composite Complete Remission (CRc) Rate	5.0 percentage of participants Interval 0.3 to 21.6	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Tumors were planned to assess on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first.

Population: Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohort B) was not initiated. Therefore, no analyses were conducted.

The ORR was defined as the percentage of participants who had a response of CR, CR equivalent, partial remission (PR), CR with limited count recovery (CRL), CRh or hematologic improvement (HI) according to IWG 2023 myelodysplastic syndrome (MDS) response criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.

Population: All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohorts A2, B and D) was not initiated. Therefore, no analyses were conducted.

The RDE of SAR443579 was determined based on the occurrence of DLTs in Cycle 1.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=20 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Expansion (Cohorts A1, A2, B and D): Recommended Dose for Expansion (RDE)	1000 mcg/kg	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation (adult), 12 weeks for dose escalation (pediatric) and 20.9 for dose expansion (Cohort A1).

Population: All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment.

An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any AE that: resulted in death; or was life-threatening; or required inpatient hospitalization or prolongation of existing hospitalization; or resulted in persistent or significant disability/incapacity; or was a congenital anomaly/birth defect; or was an important medical event. The TEAEs were defined as events that were newly reported or reported to worsen in severity after the first administration of study treatment up to 30 days after the last administration of study treatment.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=3 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 n=4 Participants Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 n=6 Participants Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 n=10 Participants Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg n=6 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg n=6 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg n=6 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=20 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Escalation and Dose Expansion (Cohort A1): Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) Any TEAE	3 Participants	4 Participants	6 Participants	10 Participants	6 Participants	4 Participants	4 Participants	8 Participants	6 Participants	4 Participants	4 Participants	7 Participants	8 Participants	6 Participants	19 Participants
Dose Escalation and Dose Expansion (Cohort A1): Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) Any treatment emergent SAE	2 Participants	3 Participants	4 Participants	7 Participants	5 Participants	3 Participants	3 Participants	3 Participants	5 Participants	2 Participants	3 Participants	5 Participants	2 Participants	4 Participants	14 Participants

SECONDARY outcome

Timeframe: At Days 1, 4, 8, 11, 15, 22, and 28 of Cycle 1

Population: The Pharmacokinetic (PK) population included all participants from all treated population with at least 1 post-baseline PK sample result with adequate documentation of dosing and sampling dates and times. During the study, participants miss few scheduled site visits for sample collection and only participants with data collected at specific timepoints are reported. The PK results for participants who received the same dose in Dose Escalation and Dose Expansion phases are presented together.

Blood samples are collected just before treatment administration during repeated dosing to determine the Ctrough of SAR443579.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=3 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 n=4 Participants Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 n=6 Participants Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 n=9 Participants Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg n=4 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg n=28 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg n=6 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg n=6 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Escalation and Dose Expansion (Cohort A1): Minimum Plasma Concentration (Ctrough) of SAR443579 Cycle 1 Day 1	0.100 nanogram per milliliter Standard Deviation 0.000	0.100 nanogram per milliliter Standard Deviation 0.000	75.000 nanogram per milliliter Standard Deviation 0.000	123.667 nanogram per milliliter Standard Deviation 50.791	75.000 nanogram per milliliter Standard Deviation 0.000	0.100 nanogram per milliliter Standard Deviation 0.000	75.000 nanogram per milliliter Standard Deviation 0.000	90.536 nanogram per milliliter Standard Deviation 82.207	75.000 nanogram per milliliter Standard Deviation 0.000	75.000 nanogram per milliliter Standard Deviation 0.000	75.000 nanogram per milliliter Standard Deviation 0.000	75.000 nanogram per milliliter Standard Deviation 0.000	75.000 nanogram per milliliter Standard Deviation 0.000	75.000 nanogram per milliliter Standard Deviation 0.000	—
Dose Escalation and Dose Expansion (Cohort A1): Minimum Plasma Concentration (Ctrough) of SAR443579 Cycle 1 Day 4	0.471 nanogram per milliliter Standard Deviation 0.155	1.271 nanogram per milliliter Standard Deviation 0.637	—	—	—	6.190 nanogram per milliliter Standard Deviation 7.161	—	—	—	—	—	—	—	—	—
Dose Escalation and Dose Expansion (Cohort A1): Minimum Plasma Concentration (Ctrough) of SAR443579 Cycle 1 Day 11	4.560 nanogram per milliliter Standard Deviation 2.307	42.600 nanogram per milliliter Standard Deviation 11.314	—	—	—	—	—	—	—	—	—	—	—	—	—
Dose Escalation and Dose Expansion (Cohort A1): Minimum Plasma Concentration (Ctrough) of SAR443579 Cycle 1 Day 8	0.885 nanogram per milliliter Standard Deviation 0.549	4.453 nanogram per milliliter Standard Deviation 1.650	1286.483 nanogram per milliliter Standard Deviation 2079.551	600.875 nanogram per milliliter Standard Deviation 649.031	75.000 nanogram per milliliter Standard Deviation 0.000	218.817 nanogram per milliliter Standard Deviation 357.961	75.000 nanogram per milliliter Standard Deviation 0.000	2135.040 nanogram per milliliter Standard Deviation 3833.753	4610.000 nanogram per milliliter Standard Deviation 5125.703	7760.000 nanogram per milliliter Standard Deviation 4910.961	1236.750 nanogram per milliliter Standard Deviation 1276.491	8004.375 nanogram per milliliter Standard Deviation 5247.014	28500.000 nanogram per milliliter Standard Deviation 7205.950	576.167 nanogram per milliliter Standard Deviation 887.893	—
Dose Escalation and Dose Expansion (Cohort A1): Minimum Plasma Concentration (Ctrough) of SAR443579 Cycle 1 Day 15	4.265 nanogram per milliliter Standard Deviation 4.148	37.185 nanogram per milliliter Standard Deviation 34.864	2972.350 nanogram per milliliter Standard Deviation 4515.051	701.500 nanogram per milliliter Standard Deviation 931.399	1343.333 nanogram per milliliter Standard Deviation 2196.818	1936.233 nanogram per milliliter Standard Deviation 2742.950	75.000 nanogram per milliliter Standard Deviation 0.000	3030.154 nanogram per milliliter Standard Deviation 3161.210	7864.333 nanogram per milliliter Standard Deviation 7975.105	13454.250 nanogram per milliliter Standard Deviation 14473.476	16595.000 nanogram per milliliter Standard Deviation 7374.738	16626.667 nanogram per milliliter Standard Deviation 7714.056	64371.429 nanogram per milliliter Standard Deviation 26631.480	2645.600 nanogram per milliliter Standard Deviation 5235.389	—
Dose Escalation and Dose Expansion (Cohort A1): Minimum Plasma Concentration (Ctrough) of SAR443579 Cycle 1 Day 28	0.241 nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant had analyzable data.	—	2537.000 nanogram per milliliter Standard Deviation 2408.406	2797.500 nanogram per milliliter Standard Deviation 3737.059	75.000 nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant had analyzable data.	8533.500 nanogram per milliliter Standard Deviation 11266.332	75.000 nanogram per milliliter Standard Deviation 0.000	5269.692 nanogram per milliliter Standard Deviation 5758.287	4922.500 nanogram per milliliter Standard Deviation 6855.400	28650.000 nanogram per milliliter Standard Deviation 18879.751	23850.000 nanogram per milliliter Standard Deviation 14354.268	25150.000 nanogram per milliliter Standard Deviation 5586.144	93825.000 nanogram per milliliter Standard Deviation 18315.453	621.000 nanogram per milliliter Standard Deviation NA Standard deviation could not be calculated as only 1 participant had analyzable data.	—
Dose Escalation and Dose Expansion (Cohort A1): Minimum Plasma Concentration (Ctrough) of SAR443579 Cycle 1 Day 22	1.528 nanogram per milliliter Standard Deviation 1.391	7.007 nanogram per milliliter Standard Deviation 5.511	3311.600 nanogram per milliliter Standard Deviation 5057.742	1307.125 nanogram per milliliter Standard Deviation 1619.001	85.000 nanogram per milliliter Standard Deviation 20.000	—	476.667 nanogram per milliliter Standard Deviation 695.707	4091.042 nanogram per milliliter Standard Deviation 4203.693	16064.250 nanogram per milliliter Standard Deviation 11077.517	14025.000 nanogram per milliliter Standard Deviation 15940.887	28700.000 nanogram per milliliter Standard Deviation 12493.465	22053.750 nanogram per milliliter Standard Deviation 13262.028	88400.000 nanogram per milliliter Standard Deviation 28175.450	391.500 nanogram per milliliter Standard Deviation 521.596	—

SECONDARY outcome

Population: The immunogenicity population included all participants from all treated population with at least 1 ADA result (positive, negative or inconclusive) post-baseline.

Plasma samples were collected to assess the antibodies to SAR443579. Treatment-emergent ADA was defined as a participant with at least 1 treatment-induced or treatment-boosted ADA-positive sample at any time during the treatment or follow-up observation period. Non-treatment emergent ADA was defined as participant without any treatment-induced, treatment-boosted ADA-positive or ADA-inconclusive sample during the treatment or follow-up observation period.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=3 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 n=3 Participants Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 n=6 Participants Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 n=10 Participants Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg n=6 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg n=3 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg n=28 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg n=6 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg n=6 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Escalation and Dose Expansion (Cohort A1): Percentage of Participants With Anti-drug Antibodies (ADA) Against SAR443579 ADA negative or missing at baseline	100 percentage of participants	100 percentage of participants	83.3 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	96.4 percentage of participants	83.3 percentage of participants	100 percentage of participants	100 percentage of participants	87.5 percentage of participants	87.5 percentage of participants	100 percentage of participants	—
Dose Escalation and Dose Expansion (Cohort A1): Percentage of Participants With Anti-drug Antibodies (ADA) Against SAR443579 ADA positive at baseline	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	3.6 percentage of participants	16.7 percentage of participants	0 percentage of participants	0 percentage of participants	12.5 percentage of participants	12.5 percentage of participants	0 percentage of participants	—
Dose Escalation and Dose Expansion (Cohort A1): Percentage of Participants With Anti-drug Antibodies (ADA) Against SAR443579 Treatment-emergent ADA	33.3 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	33.3 percentage of participants	50.0 percentage of participants	35.7 percentage of participants	33.3 percentage of participants	25.0 percentage of participants	50.0 percentage of participants	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	—
Dose Escalation and Dose Expansion (Cohort A1): Percentage of Participants With Anti-drug Antibodies (ADA) Against SAR443579 Non-treatment emergent ADA	66.7 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	83.3 percentage of participants	66.7 percentage of participants	50.0 percentage of participants	64.3 percentage of participants	66.7 percentage of participants	75.0 percentage of participants	50.0 percentage of participants	100 percentage of participants	100 percentage of participants	83.3 percentage of participants	—

SECONDARY outcome

Timeframe: Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until relapse, unacceptable AE, discontinuation or death. Maximum treatment duration: 117.3 weeks (adults) and 12 weeks (pediatrics) in dose escalation phase.

Population: All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohort C) was not initiated. Therefore, no analyses were conducted.

The CRc rate was defined as the percentage of participants who had a response of CR, CRh or CRi according to modified AML IWG 2003 response criteria. For Dose Expansion (Cohort C), the CRc rate was planned to be assessed according to NCCN.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=3 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 n=4 Participants Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 n=6 Participants Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 n=10 Participants Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg n=6 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg n=7 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg n=6 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg n=5 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Escalation and Dose Expansion (Cohort C): Composite Complete Remission Rate Assessed by Acute Myeloid Leukemia 2003 Modified International Working Group Response Criteria and National Comprehensive Cancer Network (NCCN)	0 percentage of participants Interval 0.0 to 63.2	0 percentage of participants Interval 0.0 to 52.7	0 percentage of participants Interval 0.0 to 39.3	0 percentage of participants Interval 0.0 to 25.9	0 percentage of participants Interval 0.0 to 39.3	50.0 percentage of participants Interval 9.8 to 90.2	25.0 percentage of participants Interval 1.3 to 75.1	28.6 percentage of participants Interval 5.3 to 65.9	0 percentage of participants Interval 0.0 to 39.3	0 percentage of participants Interval 0.0 to 52.7	0 percentage of participants Interval 0.0 to 52.7	0 percentage of participants Interval 0.0 to 31.2	0 percentage of participants Interval 0.0 to 31.2	20.0 percentage of participants Interval 1.0 to 65.7	—

SECONDARY outcome

Population: All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohort C) was not initiated. Therefore, no analyses were conducted.

Alternative CR rate was defined as percentage of participants with CR and CRh according to modified AML IWG 2003 response criteria.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=3 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 n=4 Participants Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 n=6 Participants Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 n=10 Participants Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg n=6 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg n=7 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg n=6 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg n=5 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Escalation and Dose Expansion (Cohort C): Alternative Complete Remission Rate	0 percentage of participants Interval 0.0 to 63.2	0 percentage of participants Interval 0.0 to 52.7	0 percentage of participants Interval 0.0 to 39.3	0 percentage of participants Interval 0.0 to 25.9	0 percentage of participants Interval 0.0 to 39.3	25.0 percentage of participants Interval 1.3 to 75.1	25.0 percentage of participants Interval 1.3 to 75.1	28.6 percentage of participants Interval 5.3 to 65.9	0 percentage of participants Interval 0.0 to 39.3	0 percentage of participants Interval 0.0 to 52.7	0 percentage of participants Interval 0.0 to 52.7	0 percentage of participants Interval 0.0 to 31.2	0 percentage of participants Interval 0.0 to 31.2	20.0 percentage of participants Interval 1.0 to 65.7	—

SECONDARY outcome

Population: All treated population included all participants who had given their informed consent and received at least any dose (even incomplete) of study treatment. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohort C) was not initiated. Therefore, no analyses were conducted.

Overall response rate was defined as percentage of participants who had a CR or CRi or CRh or PR or morphological leukemia-free state (MLFS) according to modified AML IWG 2003 response criteria.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=3 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 n=4 Participants Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 n=6 Participants Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 n=10 Participants Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg n=6 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg n=7 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg n=6 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg n=4 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg n=8 Participants Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg n=5 Participants Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Escalation and Dose Expansion (Cohort C): Overall Response Rate	0 percentage of participants Interval 0.0 to 63.2	0 percentage of participants Interval 0.0 to 52.7	0 percentage of participants Interval 0.0 to 39.3	10.0 percentage of participants Interval 0.5 to 39.4	0 percentage of participants Interval 0.0 to 39.3	50.0 percentage of participants Interval 9.8 to 90.2	25.0 percentage of participants Interval 1.3 to 75.1	28.6 percentage of participants Interval 5.3 to 65.9	0 percentage of participants Interval 0.0 to 39.3	0 percentage of participants Interval 0.0 to 52.7	0 percentage of participants Interval 0.0 to 52.7	0 percentage of participants Interval 0.0 to 31.2	0 percentage of participants Interval 0.0 to 31.2	20.0 percentage of participants Interval 1.0 to 65.7	—

SECONDARY outcome

Overall response rate was defined as percentage of participants who had a CR or CRi or CRh or PR or MLFS according to modified AML IWG 2003 response criteria.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=20 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Expansion (Cohorts A1, A2 and D): Overall Response Rate	5.0 percentage of participants Interval 0.3 to 21.6	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: All treated population included all participants who had given their informed consent and received at least any dose of study treatment. Only participants with CRc are analyzed. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2 and D) was not initiated. Therefore, no analyses were conducted.

Duration of CRc was defined as the time interval from first documented evidence of CRc (CR, CRh or CRi) until disease relapse (DR) or death due to any cause, whichever comes first.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=1 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Expansion (Cohorts A1, A2 and D): Duration of Composite Complete Remission Rate	29.0 days Interval 29.0 to 29.0	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: All treated population included all participants who had given their informed consent and received at least any dose of study treatment.Only participants with response are analyzed.Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1) for non-safety related reasons.Dose expansion/optimization part of adult and pediatric (Cohorts A2, B and D) was not initiated.Therefore, no analysis was conducted.

Duration of overall response rate was defined as the time from the first documented evidence of CR or CRi or CRh or PR or MLFS until DR or death due to any cause, whichever comes first.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=1 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Expansion (Cohorts A1, A2, B and D): Duration of Overall Response Rate	29.0 days Interval 29.0 to 29.0	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: All treated population included all participants who had given their informed consent and received at least any dose of study treatment. Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2, B and D) was not initiated. Therefore, no analyses were conducted.

Alternative CR rate was defined as percentage of participants with CR and CRh according to modified AML IWG 2003 response criteria.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=20 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Expansion (Cohorts A1, A2, B and D): Alternative Complete Remission Rate	5.0 percentage of participants Interval 0.3 to 21.6	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: All treated population included all participants who had given their informed consent and received at least any dose of study treatment.Only participants with alternative CR are analyzed.Study was terminated after completion of dose escalation of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1) for non-safety related reasons.Dose expansion/optimization part of adult and pediatric (Cohorts A2, B and D) was not initiated.Therefore, no analyses was conducted.

Duration of alternative CR was defined as the time from the first documented evidence of CR or CRh until DR or death due to any cause, whichever comes first.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=1 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Expansion (Cohorts A1, A2, B and D): Duration of Alternative Complete Remission Rate	29.0 days Interval 29.0 to 29.0	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: All treated population included all participants who had given their informed consent and received at least any dose of study treatment. Study was terminated after completion of dose escalation of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2, B and D) was not initiated. Therefore, no analyses were conducted.

The EFS was defined as the time interval from the first day of treatment assignment to the date of earliest evidence of relapse, treatment failure, or death.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=20 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Expansion (Cohorts A1, A2, B and D): Event-Free Survival (EFS)	1.0 days Interval 1.0 to 56.0	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: All treated population included all participants who had given their informed consent and received at least any dose of study treatment. Study was terminated after completion of dose escalation of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2, B and D) was not initiated. Therefore, no analyses were conducted.

The OS was defined as time interval from the first day of treatment assignment to death from any cause.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=20 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Expansion (Cohorts A1, A2, B and D): Overall Survival (OS)	2.46 months Interval 1.478 to 5.52	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: All treated population included all participants who had given their informed consent and received at least any dose of study treatment. Study was terminated after completion of dose escalation of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2, B and D) was not initiated. Therefore, no analyses were conducted.

The HSCT rate was defined as the percentage of participants who had received HSCT immediately following study treatment administration but prior to subsequent therapy for treatment of AML.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=20 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Expansion (Cohorts A1, A2, B and D): Rate of Hematopoietic Stem Cell Transplantation (HSCT)	5.0 percentage of participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: All treated population included all participants who had given their informed consent and received at least any dose of study treatment. Study was terminated after completion of dose escalation of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2, B and D) was not initiated. Therefore, no analyses were conducted.

The TTF was defined as the time from first day of treatment assignment to discontinuation for any reason excluding remission, example, relapsed disease, refractory disease, unacceptable AE, participant preference or death.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=20 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Expansion (Cohorts A1, A2, B and D): Time to Treatment Failure (TTF)	50.5 days Interval 15.0 to 145.0	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: All treated population included all participants who had given their informed consent and received at least any dose of study treatment. Study was terminated after completion of dose escalation of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult and pediatric (Cohorts A2 and D) was not initiated. Therefore, no analyses were conducted.

The TI rate was defined differently for participants who were transfusion dependency (TD) at baseline and participants who were transfusion independency (TI) at baseline. For subgroup of participants with TD at baseline, the TI rate was defined as the percentage of participants who convert from baseline TD to TI during on treatment period; For subgroup of participants with TI at baseline, the TI rate was defined as the percentage of participants who remain TI during 56-day post baseline period during treatment.

Outcome measures

Outcome measures
Measure	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=20 Participants Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A2): SAR443579 Adult participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort B): SAR443579 Adult participants with HR-MDS were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Pediatric Arm (Cohort D): SAR443579 Pediatric participants with R/R AML were planned to be received SAR443579 IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Dose Expansion (Cohorts A1, A2 and D): Transfusion Independence (TI) Rate Rate of conversion from TD to TI	0 percentage of participants Interval 0.0 to 13.9	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dose Expansion (Cohorts A1, A2 and D): Transfusion Independence (TI) Rate Rate of participants who are TI at baseline and remain independent during treatment period	10.0 percentage of participants Interval 1.8 to 28.3	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Population: Study was terminated after completion of dose escalation phase of adult and pediatric arms and dose expansion/optimization phase of adult arm (Cohort A1), for non-safety related reasons. Dose expansion/optimization part of adult (Cohort B) was not initiated. Therefore, no analyses were conducted.

The PFS was defined as the time interval from the first day of treatment assignment to the date of disease progression, relapse from CR (or CR equivalent), PR, CRL, CRh, or HI, death due to any cause, whichever comes first.

Outcome measures

Outcome data not reported

Adverse Events

Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg

Serious events: 5 serious events

Other events: 6 other events

Deaths: 6 deaths

Dose Escalation - Adult Arm: SAR443579 10-100 mcg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose Escalation - Adult Arm: SAR443579 30-300 mcg/kg

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

Dose Escalation - Adult Arm: SAR443579 750 mcg/kg

Serious events: 4 serious events

Other events: 6 other events

Deaths: 5 deaths

Dose Escalation - Adult Arm: SAR443579 800 mcg/kg

Serious events: 7 serious events

Other events: 9 other events

Deaths: 5 deaths

Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg

Serious events: 3 serious events

Other events: 8 other events

Deaths: 4 deaths

Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg

Serious events: 5 serious events

Other events: 5 other events

Deaths: 6 deaths

Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 3 deaths

Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg

Serious events: 3 serious events

Other events: 4 other events

Deaths: 4 deaths

Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg

Serious events: 5 serious events

Other events: 6 other events

Deaths: 5 deaths

Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg

Serious events: 2 serious events

Other events: 8 other events

Deaths: 8 deaths

Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg

Serious events: 4 serious events

Other events: 5 other events

Deaths: 5 deaths

Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg

Serious events: 14 serious events

Other events: 19 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg n=6 participants at risk Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 10-100 mcg/kg n=3 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 10 mcg/kg on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 30-300 mcg/kg n=4 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 750 mcg/kg n=6 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 800 mcg/kg n=10 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg n=4 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg n=4 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg n=8 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg n=6 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg n=4 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg n=4 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg n=8 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg n=8 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg n=6 participants at risk Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=20 participants at risk Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Infections and infestations Bacterial Sepsis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Covid-19	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Cellulitis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Cellulitis Orbital	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Diverticulitis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Enterococcal Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Gastrointestinal Viral Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Influenza	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Kidney Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Localised Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Metapneumovirus Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Otitis Media	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Perineal Cellulitis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Perirectal Abscess	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Pneumocystis Jirovecii Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Pneumonia	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	30.0% 3/10 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	15.0% 3/20 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Pulmonary Sepsis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Sepsis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	30.0% 3/10 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Septic Shock	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Staphylococcal Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Submandibular Abscess	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Thrombophlebitis Septic	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Urosepsis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Viral Sepsis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukaemia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Meninges	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	37.5% 3/8 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 2/20 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Immune system disorders Cytokine Release Syndrome	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Cerebellar Haemorrhage	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Haemorrhage Intracranial	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Ischaemic Stroke	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Syncope	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Vith Nerve Disorder	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Cardiac disorders Cardiac Failure	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Cardiac disorders Pericardial Effusion	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Abdominal Pain	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Colitis	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Constipation	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Enteritis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Gastric Haemorrhage	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Mouth Haemorrhage	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Hepatobiliary disorders Cholestasis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Hepatobiliary disorders Hepatic Failure	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Disease Progression	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Fatigue	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders General Physical Health Deterioration	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Multiple Organ Dysfunction Syndrome	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 2/20 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Non-Cardiac Chest Pain	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Oedema Peripheral	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Pyrexia	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Investigations Platelet Count Decreased	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Allergic Transfusion Reaction	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Surgical and medical procedures Euthanasia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.

Other adverse events

Other adverse events
Measure	Dose Escalation - Pediatric Arm: SAR443579 1500 mcg/kg n=6 participants at risk Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 10-100 mcg/kg n=3 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 10 mcg/kg on Day 1, 30 mcg/kg on Day 4 and 100 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 100 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 100 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 30-300 mcg/kg n=4 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 30 mcg/kg on Day 1, 100 mcg/kg on Day 4 and 300 mcg/kg on Days 8, 11, 15 and 22 of first 28-day cycle in induction period and SAR443579 300 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 300 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 750 mcg/kg n=6 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 750 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 750 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 800 mcg/kg n=10 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 800 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 800 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg n=4 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 100 mcg/kg on Day 1, 300 mcg/kg on Day 4 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg n=4 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 300 mcg/kg on Day 1 and 1000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000 mcg/kg n=8 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1500 mcg/kg n=6 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 1500 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1500 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 2000 mcg/kg n=4 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 2000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 2000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 1000-3000 mcg/kg n=4 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 IV infusion of 1000 mcg/kg on Day 1 and 3000 mcg/kg on Days 8, 15 and 22 of first 28-day cycle in induction period and SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to two 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 3000 mcg/kg n=8 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 3000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 3000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Adult Arm: SAR443579 6000 mcg/kg n=8 participants at risk Adult participants with either R/R AML or HR-MDS received SAR443579 6000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 6000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Escalation - Pediatric Arm: SAR443579 1000 mcg/kg n=6 participants at risk Pediatric participants with R/R AML, B-ALL or BPDCN received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.	Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg n=20 participants at risk Adult participants with R/R AML received SAR443579 1000 mcg/kg IV infusion once weekly (Days 1, 8, 15 and 22) up to three 28-day cycles in induction period and then continued to receive SAR443579 1000 mcg/kg IV infusion every 4 weeks (Days 1 and 29) up to thirteen 56-day cycles in maintenance period, or disease progression, or occurrence of unacceptable toxicity, or other permanent discontinuation criteria.
Infections and infestations Bacteraemia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Covid-19	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Catheter Site Cellulitis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Ear Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Erysipelas	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Hcov-Hku1 Infection	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Hcov-Oc43 Infection	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Influenza	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Oral Candidiasis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Oral Herpes	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 2/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Parainfluenzae Virus Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Pain	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Paronychia	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Pneumonia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Pneumonia Fungal	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Respiratory Tract Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Salmonellosis	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Sinusitis	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Sinusitis Aspergillus	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Staphylococcal Sepsis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Streptococcal Bacteraemia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Tooth Abscess	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Tooth Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Urinary Tract Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 2/6 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Vascular Device Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Viral Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Meninges	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Papilloma	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Blood and lymphatic system disorders Coagulopathy	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Blood and lymphatic system disorders Febrile Neutropenia	33.3% 2/6 • Number of events 4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 2/20 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Immune system disorders Cytokine Release Syndrome	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 2/20 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Immune system disorders Drug Hypersensitivity	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Metabolism and nutrition disorders Decreased Appetite	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 2/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 2/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Metabolism and nutrition disorders Gout	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Psychiatric disorders Anxiety	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Psychiatric disorders Confusional State	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Psychiatric disorders Depression	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Psychiatric disorders Insomnia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	20.0% 2/10 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Psychiatric disorders Irritability	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Aphasia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Dizziness	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	20.0% 2/10 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 2/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Dysgeusia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Facial Paresis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Headache	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 2/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	20.0% 2/10 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 2/20 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Neuropathy Peripheral	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Polyneuropathy	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Presyncope	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Restless Legs Syndrome	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Nervous system disorders Somnolence	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Eye disorders Blepharitis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Eye disorders Conjunctival Haemorrhage	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 2/20 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Eye disorders Eye Swelling	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Cardiac disorders Bradycardia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Cardiac disorders Coronary Artery Disease	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Cardiac disorders Mitral Valve Incompetence	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Cardiac disorders Palpitations	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Cardiac disorders Pericardial Effusion	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Cardiac disorders Sinus Bradycardia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Cardiac disorders Sinus Tachycardia	16.7% 1/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Cardiac disorders Tachycardia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Vascular disorders Aortitis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Vascular disorders Flushing	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Vascular disorders Haematoma	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Vascular disorders Hypertension	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 3/6 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 2/20 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Vascular disorders Hypotension	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	20.0% 2/10 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Vascular disorders Orthostatic Hypotension	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Vascular disorders Peripheral Vein Thrombosis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	37.5% 3/8 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 2/20 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 2/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Epistaxis	50.0% 3/6 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	20.0% 2/10 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 2/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 2/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	15.0% 3/20 • Number of events 4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Lung Infiltration	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Nasal Dryness	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Nasal Inflammation	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 2/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Paranasal Sinus Discomfort	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 3/6 • Number of events 4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Abdominal Distension	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Abdominal Pain	50.0% 3/6 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Anal Fissure	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Anal Haemorrhage	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Anal Incontinence	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Aphthous Ulcer	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Cheilitis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Colitis	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Constipation	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	66.7% 2/3 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	20.0% 2/10 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 2/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 2/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 2/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	15.0% 3/20 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Diarrhoea	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 2/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	20.0% 4/20 • Number of events 4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Dry Mouth	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	15.0% 3/20 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Flatulence	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Gingival Bleeding	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Gingival Hypertrophy	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Gingival Oedema	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Gingival Pain	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Haematochezia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Lip Dry	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Lip Swelling	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Mouth Haemorrhage	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Mouth Ulceration	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 2/4 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	20.0% 2/10 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 2/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 2/20 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Oesophagitis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Oral Purpura	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Post-Tussive Vomiting	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Stomatitis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	20.0% 2/10 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	75.0% 3/4 • Number of events 4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 2/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 2/20 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Tongue Haemorrhage	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Gastrointestinal disorders Vomiting	33.3% 2/6 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 2/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 2/20 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Hepatobiliary disorders Hepatic Cytolysis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Hepatobiliary disorders Hepatic Steatosis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Hepatobiliary disorders Hepatomegaly	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Blister	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Hyperhidrosis	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Ingrowing Nail	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Petechiae	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Rash Erythematous	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Rash Morbilliform	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Rash Pruritic	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Skin Haemorrhage	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Skin Lesion	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Skin and subcutaneous tissue disorders Skin Ulcer	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	30.0% 3/10 • Number of events 4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 2/4 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 2/20 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Bone Cyst	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Crystal Arthropathy	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 2/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Greater Trochanteric Pain Syndrome	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Muscle Spasms	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Pain In Extremity	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	37.5% 3/8 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Renal and urinary disorders Dysuria	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Renal and urinary disorders Haematuria	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Renal and urinary disorders Micturition Urgency	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Renal and urinary disorders Pollakiuria	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Renal and urinary disorders Urinary Incontinence	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Reproductive system and breast disorders Erectile Dysfunction	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Reproductive system and breast disorders Prostatitis	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Reproductive system and breast disorders Vaginal Haemorrhage	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Congenital, familial and genetic disorders Factor Xiii Deficiency	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Asthenia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Catheter Site Irritation	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Catheter Site Oedema	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Catheter Site Pain	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Chest Discomfort	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Chills	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Face Oedema	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Fatigue	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	30.0% 3/10 • Number of events 5 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	15.0% 3/20 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Generalised Oedema	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Hypothermia	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Influenza Like Illness	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Infusion Site Extravasation	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Localised Oedema	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Malaise	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Non-Cardiac Chest Pain	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 2/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	5.0% 1/20 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Oedema Peripheral	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 2/8 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 2/6 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	30.0% 6/20 • Number of events 8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Peripheral Swelling	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Pyrexia	33.3% 2/6 • Number of events 6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 2/4 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	15.0% 3/20 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
General disorders Swelling Face	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Investigations Alanine Aminotransferase Increased	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Investigations Cardiac Murmur	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Investigations Neutrophil Count Decreased	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Compression Fracture	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Contusion	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Head Injury	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Hip Fracture	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Infusion Related Reaction	66.7% 4/6 • Number of events 8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	75.0% 3/4 • Number of events 5 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 2/6 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	60.0% 6/10 • Number of events 6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	100.0% 4/4 • Number of events 8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	87.5% 7/8 • Number of events 12 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 3/6 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 2/4 • Number of events 7 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 2/4 • Number of events 3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	50.0% 4/8 • Number of events 7 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	75.0% 6/8 • Number of events 8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 2/6 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	65.0% 13/20 • Number of events 15 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Post Procedural Haematoma	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	33.3% 1/3 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Procedural Site Reaction	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Skin Abrasion	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	12.5% 1/8 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Subcutaneous Haematoma	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Subdural Haemorrhage	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/10 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.
Injury, poisoning and procedural complications Transfusion Reaction	16.7% 1/6 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/3 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	10.0% 1/10 • Number of events 2 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/4 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	25.0% 1/4 • Number of events 1 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/8 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/6 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.	0.00% 0/20 • SAEs and other AEs were collected from the first dose of study drug administration (Day 1) up to early termination of the study, maximum treatment duration was 117.3 weeks for dose escalation - adult arms, 12 weeks for dose escalation - pediatric arms and 20.9 for dose expansion - adult arm (Cohort A1). All-cause mortality was collected from the first dose of study drug administration (Day 1) up to the longest duration of survival follow up for each participant; maximum duration being 90 weeks. Analysis was performed on the all treated population.

Additional Information

Trial Transparency Team

Sanofi aventis recherche & développement

Phone: 800-633-1610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
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